IMOVAX Polio® Ipol® Vaccine
Sanofi Pasteur's single-antigen inactivated poliovirus vaccine (IPV) Imovax Polio®; Ipol® is highly purified, with enhanced potency, says the U.S. Food and Drug Administration (FDA). The IPOL is a sterile suspension consisting of three types of poliovirus that have been chemically killed: Type 1 (Mahoney), Type 2 (MEF-1), and Type 3 (Saukett). In addition, some combination vaccines (different vaccines contained in the same dose) contain IPV, such as Pentacel (DTaP-IPV/Hib), and IPOL is the IPV included in the children's vaccine series Pentacel and Quadracel.
The U.S. Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) reviewed and voted on updated IPV vaccination guidance on June 21, 2023. The ACIP reviewed a presentation on October 19, 2022, that confirmed IPV induces some nasopharyngeal mucosal immunity but limited intestinal immunity. However, IPV induces effective humoral immunity and prevents paralysis with about 90% seroprotection after two doses. Children in the USA should get an IPV to protect against poliomyelitis, according to the U.S. CDC's 2023 vaccination schedule. In addition, the CDC says children traveling to countries with a risk of contracting poliovirus should complete the series before departing says the CDC. Most adults do not need a polio vaccine booster because they were vaccinated as children unless visiting polio outbreaks.
The WHO's Prequalification date was 09/12/2005. For more information, visit Sanofi Pasteur Vaccines.
Fractional-Dose IPV
The U.S. CDC says Fractional IPV (fIPV) is administered intradermally using one-fifth of the regular dose. The use of fIPV has been recommended by WHO as a response strategy for VDPV2 outbreaks. In July 2017, the WHO/PAHO published a Practical Guide to support countries in planning and implementing fIPV in the routine immunization schedule. Currently, fIPV is not recognized as a dose to satisfy immunization requirements in the U.S.
IMOVAX IPOL Indication
Polio immunization has been available in the USA since 1955 and has been part of the U.S. CDC's routine childhood immunization schedule for decades. The IPOL vaccine is indicated for active immunization of infants (as young as six weeks), children, and adults to prevent poliomyelitis caused by poliovirus types 1, 2, and 3.
IMOVAX IPOL Dosage
IPOL is administered intramuscularly or subcutaneously. Single-antigen IPV is distributed in single-dose syringes or 10-dose vials. The recommended dose for both children and adults is 0.5 mL. It can be administered by the intramuscular or subcutaneous route, using a needle length appropriate for the age and size of the vaccine recipient.
IMOVAX IPOL Active Substance
IPOL Vaccine Active substance: Inactivated Poliovirus type 1 (Mahoney) 40D antigen units Inactivated Poliovirus type 2 (MEF-1) 8D antigen units Inactivated Poliovirus type 3 (Saukett) 32D antigen units.
Poliomyelitis
Poliomyelitis is a highly infectious disease caused by a virus that can invade the nervous system and cause total paralysis in hours. The virus enters the body through the mouth and replicates in the intestine. Initial symptoms are fever, fatigue, headache, vomiting, neck stiffness, and limb pain. One in 200 infections leads to irreversible paralysis (usually in the legs). Among those paralyzed, 5% to 10% die when their breathing muscles become immobilized, says the World Health Organization.
IMOVAX IPOL Vaccine News
May 12, 2023 - The U.S. CDC reported From January 1, 2021–March 31, 2023, GPEI supported 48 countries in implementing 219 SIAs, during which approximately 988 million bOPV, 616,000 IPV, 960,000 fractional IPV, 90 million mOPV2, 595 million nOPV2, and 100 million tOPV doses were administered.
October 12, 2022 - The Lancet published an analysis that stated: Polio outbreak risk can be exacerbated in countries using inactivated polio vaccine, which offers excellent protection against paralysis but is less effective than an oral vaccine against poliovirus shedding, potentially allowing circulation without detection of paralytic cases
October 5, 2022 - Cattaraugus County, New York, Public Health Director Dr. Kevin D. Watkins is urging county residents who are not vaccinated against polio to get vaccinated. Currently, polio cases have been upstate New York.
September 28, 2022 - New York State Health Commissioner Dr. Mary T. Bassett declared poliovirus an imminent threat to public health in New York State, thereby expanding the availability of funding and resources to support local health departments in establishing immunization clinics, deploying vaccines to health care partners, and conducting outreach to unvaccinated and under-vaccinated New Yorkers to increase immunization rates, particularly in the areas affected by the virus and among children.
September 28, 2022 - HEALTH ADVISORY: Update #3 Regarding Poliovirus in New York State. If an adult at risk has reason to believe they were not vaccinated. Records cannot be easily and quickly obtained, so treat them as not vaccinated. In addition, all children and adolescents (up to 17 years of age) who are unvaccinated or undervaccinated should be brought up to date with all routine CDC-recommended IPV doses. This is particularly urgent if they live, work, attend school, or have frequent social interactions with communities where poliovirus has been repeatedly detected in wastewater (currently Rockland, Orange, and Sullivan Counties).
September 26, 2022 - Due to a recent confirmed poliovirus case in New York, a bordering state, the New Jersey Department of Health (NJDOH) requests that healthcare provider offices and pharmacies consider stocking IPV to increase access for people seeking vaccination.
August 4, 2022 - The New York State Department of Health stated: "This unprecedented circulation of polio in our community must be stopped. Any unvaccinated children and adults should receive a first polio immunization immediately."
April 26, 2022 - The rise of vaccine-derived polio cases has almost tripled from 2019 to 2020.
March 27, 2022 - The 'Two Drops' campaign will be kicked off in Israel after health officials confirmed the first case of the potentially debilitating disease in the country in over 30 years.
December 11, 2019 - FDA: Poliovirus Vaccine Inactivated (Monkey Kidney Cell). IPOL vaccine is indicated for active immunization of infants (as young as six weeks of age), children, and adults to prevent poliomyelitis caused by poliovirus types 1, 2, and 3.
March 25, 2015 - Sanofi Pasteur announced that the U.S. FDA approved the use of Quadracel™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine for active immunization against diphtheria, tetanus, pertussis, and poliomyelitis in children 4 through 6 years of age.
December 11, 1987 - Recommendations of the CDC Immunization Practices Advisory Committee Poliomyelitis Prevention: Enhanced-Potency Inactivated Poliomyelitis Vaccine -- Supplementary Statement.
IMOVAX IPOL Clinical Trials
IPOL has been tested in multiple clinical trials. Click here to review all the trials.
The primary objective of this Phase III trial is to compare IMOVAX Polio to the current Chinese standard of care (OPV) that is administered following a schedule of 2-3-4 months. The objective is to demonstrate that after the three-dose primary series, in terms of seroprotection rates, IMOVAX Polio is not inferior to OPV. In addition, the safety of IPV will be assessed after each IPV dose.
Clinical Safety Evaluation Phase 3 Study of the Sanofi Pasteur's Inactivated Poliomyelitis Vaccine (IMOVAX Polio™) Administered as a Single Booster Dose at 18 Months of Age in Healthy Chinese Children and as the First Dose of Primary Vaccination at 2 Months of Age in Healthy Chinese Infants.
The primary objective of this Phase 2 study is to demonstrate the non-inferiority of fractional doses of IMOVAX Polio administered intradermally versus full doses of IMOVAX Polio administered intramuscularly in terms of seroprotection rates (polio types 1,2 and 3) one month after the three-dose primary vaccination administered at 6-10-14 weeks of age.
